Catheter assembly

ABSTRACT

A multi lumen catheter assembly. The assembly provides an expandable, low profile, fixed length sheath and catheter, with fixed infusion ports. The assembly has an expandable outer sheath that expands upon pressure activation with a fluid and the sheath allows the fluid to exit from at least one predetermined fixed location from a distal end of the catheter assembly. The catheter assembly can be used in various medical device procedures, such as a TIPS (Transjugular Intrahepatic Portosystemic Shunt) procedure, or anywhere a low profile, multi lumen, infusion catheter system is desired.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a national phase application of PCT Application No.PCT/US2016/035700, filed Jun. 3, 2016, which claims priority to U.S.Provisional Application No. 62/171,392, filed Jun. 5, 2015, both ofwhich are herein incorporated by reference for all purposes.

FIELD

The present disclosure relates to catheters associated with implantablemedical devices and, more particularly, relates to low profile catheterassemblies with multiple channels capable of delivering fluids tomultiple locations.

BACKGROUND

The use of implantable medical devices in the treatment of diseasedvasculature and other body conduits has become commonplace in themedical field. Such devices can be surgically implanted in or deliveredendoluminally to the treatment site. In the latter case, visualizationof the vasculature and the device can be challenging. Typically,caregivers and/or operators use a catheter for injection contrast to aidin visualization during the treatment. Moreover, vessel hydration ordelivery of medicaments to the anatomy in association with delivery ofsuch devices may be desirable. A catheter has a profile that indicateswhat size introducer the catheter can be inserted through. Adding multilumen capabilities to a catheter tends to increase the overall catheterprofile. In some previously known catheters, an additional lumen meanshaving multiple fixed lumen diameters (i.e., the lumen diameters do notchange significantly under normal operating procedures) and therebyhaving an increased profile compared to a single lumen catheter. In someother previously known catheters, an expandable sheath is used as asecondary lumen and at least partially addresses the increased profileby allowing the expandable sheath to expand and contract.

These previously known catheters still have limitations and leave roomfor improvements, especially in difficult procedures. Therefore, itremains desirable to provide a multi-channel catheter that facilitatesaccurate and efficient endoluminal deployment of implantable devices andendovascular tools.

SUMMARY

Various examples of catheter assemblies and associated systems andmethods in accordance with the present disclosure relate to medicaldevices with multiple lumens usable for delivery of fluid(s) to one ormore desired locations in the anatomy. In some examples, a catheterassembly in accordance with the present disclosure is usable to deliverfluids (e.g., contrast solution or fluid) to desired location(s) in bodylumens, such as the vasculature of a patient (e.g., in the region of aportosystemic shunt, the aorta, or other vasculature either venous orarterial).

In some examples, a catheter assembly in accordance with the presentdisclosure includes a sheath attached to an elongated member of amedical device (e.g., a shaft and/or hub of a catheter assembly) at oneor more attachment location(s) to form one or more lumens for fluiddelivery. Some examples relate to a catheter assembly having anelongated tubular element (e.g., a catheter shaft, a balloon catheter,etc.) with an outer surface, a first end and a second end, a lengthextending between the first end and the second end, and a lumenextending along the elongated element. A sheath surrounds at least aportion of the length of the elongated element, wherein the sheathcomprises a wall thickness, an outer surface area, a first relaxedconfiguration and a second pressurized configuration. In some examples,the sheath is attached to the elongated element at opposingcircumferential ends of the sheath and cooperates with the elongatedelement to form one or more channels along at least a portion of thelength of the elongated element when the sheath is in the secondpressurized configuration. In some examples, the sheath comprises atleast one macroscopic aperture through the wall thickness. In someexamples, the at least one macroscopic aperture(s) have a macroscopicaperture area, wherein the macroscopic aperture area of the macroscopicaperture(s) occupies 20% or less of the surface area of the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the present disclosure and are incorporated in andconstitute a part of this specification, illustrate embodiments of thepresent disclosure, and together with the description serve to explainthe principles of the present disclosure.

FIG. 1 shows an isometric view of a catheter with a relaxed outer sheathin accordance with the present disclosure.

FIGS. 2A-2D show transverse cross sections taken at a location along alength of several embodiments of a catheter assembly in accordance withthe present disclosure.

FIG. 3 shows an isometric view of a catheter with an expanded outersheath in accordance with the present disclosure.

FIGS. 4A-4C show transverse cross sections taken at a location along alength of several embodiments of a catheter assembly in accordance withthe present disclosure.

FIGS. 5A-5D show longitudinal cross sections of a catheter, hub, andsheath in accordance with the present disclosure.

FIGS. 6 and 7 show schematic representations of anatomy that isapplicable to use of the catheter assembly in accordance with thepresent disclosure.

DETAILED DESCRIPTION

In some examples, catheter assemblies according to the presentdisclosure are usable to deliver fluids to vasculature or otherlocations in a body. For example, a catheter assembly may transportcontrast fluid within the body, or any of a variety of fluids includingsaline, medicaments (pharmaceutical or other therapeutic agents), blood,serum, or other fluids as desired.

In various examples, catheter assemblies described herein have anadditional component or layer added along the catheter to aid indelivering fluids within the body. This additional layer may besurrounding at least a portion of an outer surface of the catheter. Forexample, as shown in FIG. 1, a catheter assembly 100 has an elongatemember 102 (e.g., a catheter, guidewire, tube, etc.), a hub 108 with ahub proximal side delivery port 110, a hub distal side delivery port112, a hub proximal end fluid delivery port 114, and a hub distal end124 with a port, and an additional layer (e.g., a sheath 104) along thecatheter outer surface 103. A catheter typically has an outside diameterand an inside diameter, thereby having a lumen at least partially alongthe catheter.

As shown in FIG. 1, the catheter assembly 100 defines a catheterassembly length 107. As also shown, the sheath 104 defines a firstsheath length 130 (e.g., corresponding to a total length of the sheath104 between proximal and distal ends) and a second sheath length 120(e.g., corresponding to a length of the sheath 104 from a distal end ofthe hub to the distal end of the sheath 104). As shown, the catheterassembly length 107 extends between hub proximal end port 114 andcatheter assembly distal end 116 and measures between hub proximal endport 114 and catheter assembly distal end 116 longitudinally alongelongated element 102 (a catheter as shown, although other elongatedelements are contemplated as previously described). As also shown, thefirst sheath length 130 extends between sheath proximal end 132 andsheath distal end 118 longitudinally along catheter 102. The proximalend 132 of sheath 104 may extend to any location along hub length 126 asdesired. As shown, the second sheath length 120 is defined between hubdistal end 124 and sheath distal end 118. Sheath 104 may extend along alength portion of catheter 102 as desired (e.g., along catheter outersurface 103) and along at least a portion of hub 108 as desired (e.g.,along hub outer surface 109).

The desired attachment location(s) between the elongate member 102 andthe sheath 104, the catheter assembly length 107, the catheter effectivelength 106, the first sheath length 130 and the second sheath length 120may vary per application and therefore may vary sheath offset length121. For example, the catheter assembly length 107 may be 40 cm (inother cases the catheter assembly length may be 50 cm, 60 cm, or 70 cmor more). For example, the sheath offset length 121 may be 10 cm. Inother cases, the sheath offset length 121 may be 8 cm, 6 cm, 4 cm orless. In a TIPS (Transjugular Intrahepatic Portosystemic Shunt)application, a sheath offset length 121 of 10 cm may be useful for atypical anatomy. Hub length 126 extends between hub proximal end port114 and hub distal end 124.

The sheath 104 and the sheath apertures 122 have associated surfaceareas. The sheath apertures 122 can encompass varying amounts of areaand therefore varying ratios of the sheath 104 total surface area. Forexample, the sheath apertures 122 surface area may account forapproximately 20% of the total surface area of the sheath 104. In othercases, the sheath apertures may account for 18%, 16%, 14%, 12%, 10%, 5%,1%, or even less than 1%. The area calculations are taken when thecatheter assembly is in a non-pressurized state as shown in FIG. 1. Thesheath aperture areas and sheath areas can be measured using standardknown area calculating techniques. A sheath aperture is consideredmacroscopic if fluid can be passed through the aperture by a syringeunder normal clinical operating pressures.

In some examples (e.g., as shown in FIGS. 1, 3, 5A, 5B and 5C) thesheath 104 is attached circumferentially to the catheter 102, at alocation distal to at least one of the macroscopic sheath apertures 122.As shown, the sheath 104 is also attached circumferentially to anotherportion of the catheter assembly 100 at an opposing end of the sheath104 (e.g., at an intermediate location on catheter 102, at a distal endof catheter 102, or at another location along catheter 102 as desired).

In various ways, a sheath can surround a catheter. For example, as shownin transverse cross section 128 of catheter assembly 100 in FIG. 2A, thesheath 104 may more tightly surround catheter 102. Sheath inner surface200 may be in contact entirely with catheter outer surface 103, therebyhaving no significant voids or sheath pockets 204 (e.g., transversecross section 128 of catheter assembly 100 in FIG. 2B). Alternatively,as shown in FIG. 2B, the sheath 104 may be more loosely fitted along thecatheter 102. Sheath inner surface 200 may partially contact catheterouter surface 103, thereby creating sheath pockets 204 along thecatheter outer surface 103. The sheath pockets 204 tend to be morelocalized and not run a continuous channel between sheath apertures 122and hub distal fluid delivery port 112. In each of these examples, thesheath 104 is in a relaxed configuration (i.e., not pressurized by anexternally supplied force, e.g., a syringe). Sheath 104 may subsequentlybe expanded by an externally supplied force (e.g., to produce aninternal fluid pressure in the channel) supplied by an external pressuredevice (e.g., a syringe) to create a fluid channel(s) 400, 401 as shownin transverse cross sections 300 of catheter assembly 100 in FIGS. 2Cand 2D (see also FIG. 4C).

In some examples, the sheath 104 is configured to be distended by aninternal pressure and to elastically recover upon removal of theinternal pressure. Additionally or alternatively, the sheath 104 can beloosely fitted around the catheter 102 such that upon internalpressurization the loose portions of the sheath 104 are expandable to apressurized configuration and upon removal of the internalpressurization the loose portions of the sheath 104 return to therelaxed configuration. The sheath 104 is optionally formed offluoropolymer materials, such as expanded PTFE (“ePTFE”), or othermaterials such as silicone, polyurethane, polyethylene terephthalate orothers. In some examples, the sheath 104 includes one or more elasticlayer(s) or component(s), such as a separate elastomeric layer (e.g., asilicone or polyurethane layer) or an elastomer component within a layer(e.g., silicone coated onto or imbibed within an ePTFE layer).

In some examples, the catheter assembly 100, and in particular thesheath 104, has a first relaxed configuration circumference and a secondpressurized configuration circumference that is greater than the firstrelaxed configuration circumference. For example, as shown in FIG. 2C,FIG. 2D, and FIG. 4C, a length (e.g., a circumference) along sheathouter surface 105 in a pressurized configuration is greater than alength (e.g., a circumference) along sheath outer surface 105 in anon-pressurized configuration. In some examples, the sheath 104transitions to the pressurized configuration upon application of aninternal fluid pressure. After pressure (e.g., internal fluid pressure)has been released, the sheath returns towards its originalnon-pressurized configuration. As previously referenced, any of avariety of fluids may be used for pressurization, including contrastsolution, saline, medicaments, blood, serum, or other fluids.

In various embodiments, a sheath may transition from a restingconfiguration towards a pressurized configuration upon pressurizing thesheath (e.g., with an internal fluid pressure). Transverse crosssections 128 of catheter assembly 100 (as shown in FIGS. 2A, 2B, andFIGS. 4A, 4B) show a sheath 104 in a relaxed, resting state against thecatheter 102. When the sheath is pressurized through at least one of twoside hub ports (e.g., 112 as shown in FIG. 5A), the sheath 104 movesaway from the catheter 102 towards a more pressurized, non-relaxedconfiguration, as shown in various pressurization stages as shown byFIGS. 2C, 2D, and FIG. 3. For example, a partial fluid channel(s) 401may form, urging the sheath 104 away from the catheter 102, as shown intransverse cross section 300 of catheter assembly 100 in FIG. 2C, when acontinuous space forms from a hub port (e.g., hub distal fluid deliveryport 112) to sheath apertures 122. The partial fluid channel(s) 401 maytransition into a sheath full fluid channel 400, as shown in transversecross section 300 of catheter assembly 100 in FIG. 2D when the catheterassembly is in a pressurized configuration. The sheath full fluidchannel 400 forms when a fluid urges the entire sheath inner surface 200away from a contacting surface (e.g., a catheter outer surface 103 orhub outer surface 109) entirely and forms a continuous space from a hubport (e.g., hub distal fluid delivery port 112) and sheath apertures122. Alternatively, the partial fluid channel(s) 401 may form (FIG. 2C)and not transition into a sheath full fluid channel 400 (as shown inFIG. 2D). For example, by selectively keeping portions of the sheath 104against catheter outer surface 103 (e.g., by tacking down or adheringportions of the sheath 104 to catheter 102 at desired attachmentlocation(s) 402 as shown in FIG. 2C). The attachment location(s) 402attach, press, or keep portions of the sheath 104 (or in some otherfashion) against catheter outer surface 103.

A catheter assembly may have multiple fluid channels. As shown byexample in FIG. 2D, a catheter assembly 100 may have a first fluidchannel (e.g., a catheter lumen 119) associated with a fluid deliveryport 110 (as shown in FIG. 1) and a second fluid channel (e.g., 400,401)that is associated with a fluid delivery port 112 (as shown in FIG. 1).One or both of the fluid channels are configured to receive and conveypressurized fluids, for example.

In various ways, a sheath may be attached to a catheter. For example,the sheath 104 may be attached at one or more attachment location(s)402. In some examples, the sheath 104 is attached at sheath distal end118 as shown in FIG. 1 and FIG. 3 at attachment location 402D, althoughintermediate or proximal locations are additionally or alternativelycontemplated. The attachment location(s) 402 may be entirely around acatheter 102 circumference at a location along catheter effective length106 as shown in FIG. 1 and FIG. 3. Alternatively, the attachmentlocation(s) 402 may not be sealed totally against the catheter 102(e.g., not sealed against the catheter 102 at the sheath distal end118). In some examples where the attachment location 402D is not sealedtotally against the catheter, the sheath 104 allows some fluid to travelalong the sheath 104 and to exit past the sheath distal end 118 and insome cases exit through sheath apertures 122 and past sheath distal end118. The attachment location(s) 402 may help build pressure within thesheath 104 allowing the sheath to expand when fluid is injected. Theattachment location(s) 402 also may help keep the sheath 104 at a fixedlocation along the catheter 102.

The sheath 104 may also bound (surround) the catheter 102 but onlypartially around the catheter outer surface 103 for a given transversecross section 128 as shown in FIG. 4A and FIG. 4B. This may help keep alower profile than a sheath that entirely surrounds catheter 102, whilestill allowing a fluid channel to form along the catheter 102 and sheath104 and exit sheath apertures 122 at a fixed location along the catheter102. FIG. 4C shows a sheath 104 partially surrounding a catheter 102with a sheath full fluid channel 400 (e.g., after being pressurized byan external pressure source).

FIGS. 5A and 5B show a magnified longitudinal cross section view of hub108, catheter 102, and sheath 104 in accordance with this disclosure(with FIG. 5B describing an enlarged portion of FIG. 5A). The hub 108has a plurality of fluid delivery ports (first and second side ports asshown in FIGS. 1, 5A and 5B), including a hub distal delivery port 112and a hub proximal delivery port 110, each of which can be used todeliver a fluid to one or more locations (e.g., contrast solution oranother fluid at two separate, first and second locations along thelength of the catheter 102). A fluid may be injected through the hubdistal fluid delivery port 112 into a hub fluid space 500. In oneexample, the hub fluid space 500 is a toroidal shape (e.g., in atransverse cross section taken transversely to hub fluid space length127), as shown in FIG. 5A and FIG. 5B. The hub fluid space 500 may varyalong hub fluid space length 127 as shown in FIG. 5A (or alternativelymay have constant dimensions along the hub fluid space length 127). Thetoroidal shape may allow a fluid to more easily expand the sheath 104 inan annular fashion by allowing fluid to more easily fill sheath innersurface 200. The fluid space 500 may have other features such asprotrusions that may rifle or spin the fluid along the hub fluid spacelength 127 and along the sheath 104 and catheter 102. In other examples,the hub fluid space 500 may be a channel or lumen that is not annular.

In various ways, sheath 104 may attach to hub 108. In one example, asshown in FIG. 5A, the sheath 104 surrounds hub outside surface 109. Thesheath 104 is attached along hub outside surface 109 and sheath innersurface 200 at one or more attachment location(s) 402, such as aproximal attachment location 402P, so fluid will not leak between thesheath 104 and the hub outside surface 109.

In another example, the sheath 104 is sealed along hub fluid space 500.Sheath outer surface 105 is sealed along hub fluid space inner surface502, as shown in FIG. 5C.

In still other examples, multiple sheaths (e.g., multiple, concentricsheaths) are attached to the hub 108 to form multiple fluid spaces. Forexample, FIG. 5D shows sheath 104 surrounding catheter 102 and sheath104D concentrically surrounding sheath 104 and catheter 102 to formmultiple sheath fluid channels. Hub 108 defines more than one fluidspace, such as fluid space 500 and fluid space 500D. Each of the fluidspaces 500, 500D is in communication with a fluid port (not shown) ofthe hub 108. As shown, sheath outer surface 105 is sealed along hubfluid space inner surface 502 and sheath outer surface 105D is sealedalong hub fluid space inner surface 502D. In various examples, thesheaths 104, 104D are configured to deliver a fluid through the fluidchannels defined between sheath inner surface 200 and the catheter outersurface 103 and between the sheath inner surface 200D and sheath outersurface 105. The sheaths 104, 104D may be different lengths and havedifferent distal openings and/or macroscopic apertures as desired.Additionally, the sheath 104D is optionally secured to the sheath 104 atone or more desired attachment location(s).

FIG. 6 is a generalized schematic of venous anatomy in proximity of theliver. FIG. 6 generally illustrates a parenchymal tract 600 of the liver605 between a portal vein 602 and hepatic vein 604. For ease ofillustration, not all anatomical features are to scale or represented(e.g., the vena cava), although such anatomical features are wellunderstood as are methods of forming parenchymal tracts (e.g., inassociation with a Transjugular Intrahepatic Portosystemic Shunt (TIPS)procedure. In some medical procedures, for example in a TransjugularIntrahepatic Portosystemic Shunt (TIPS) procedure, after forming of aliver parenchymal tract 600 (FIG. 6), catheter assembly 100 may beinserted into the vasculature and the tract 600 and utilized tovisualize the tract 600 and length of the tract to determine how long ofan endoprosthesis may be required to support the tract 600. The catheterassembly 100 is placed in the tract 600 of liver 605 between portal vein602 and hepatic vein 604. The sheath apertures 122 can be located in thehepatic vein 604 and the catheter assembly distal end 116 can be locatedin the portal vein 602, allowing fluid to be injected through ports(112,110 as shown in FIG. 1) and exit sheath apertures 122 and catheterassembly distal end 116 via catheter lumen 119 (may be used as a fluidchannel), also as shown in FIG. 1. The fluid can follow blood flow asindicated by arrows 606. The fluid can be injected simultaneously at twodifferent locations along the length of the catheter assembly 100 tovisualize the hepatic vein 604 and portal vein 602 at the same time.Alternatively, the fluid can be injected at different times.

In various examples, catheter assembly 100 may incorporate othercomponents. For example, catheter assembly 100 may incorporate anendoprosthesis. The endoprosthesis may be located along the elongatedtubular element, (e.g., catheter shaft 102 or perhaps a balloon cathetershaft), between sheath distal end 118 and the elongated tubular elementdistal end (e.g., catheter assembly distal end 116). This may beadvantageous in various ways. For example, it may allow a user to nothave to exchange catheter assembly 100 before implanting anendoprosthesis during a medical procedure.

In other medical procedures, for example a procedure where a catheterresides in a vasculature (arterial or venous) for a time sufficient toallow a catheter to adhere to a vessel, catheter assemblies described inthe present disclosure may also prove to be useful. For instance, in aTAMBE (Thoracoabdominal Modular Branched Endoprosthesis) procedure, acatheter assembly 100 (as shown in FIG. 7) could undesirably adhere to avessel 700 (e.g., an iliac artery) at an adhesion, or attachmentlocation 702 during the procedure.

A catheter assembly 100 according to this disclosure would allow aphysician or user to inject a fluid into the sheath 104 and exit sheathapertures 122 and catheter assembly distal end 116 to help preventadhesion to a vessel wall (e.g., by applying preventative hydration atone or more potential adhesion location(s) or by applying preventativehydration at one or more locations upstream of the potential adhesionlocation(s)). The hydration may hydrate the vessel tissue and/or mayhydrate the catheter assembly (e.g., where one or more components of thecatheter assembly includes a hydrophilic coating, such as a hydrophiliccatheter shaft).

Additionally or alternatively, the catheter assembly 100 may be used tohelp in releasing the catheter assembly 100 from the vessel (e.g., iliacartery) at adhesion location 702 that the sheath 104 and/or catheter 102is attached to. The rehydration may hydrate the vessel tissue and/or mayrehydrate the catheter assembly (e.g., where one or more components ofthe catheter assembly includes a hydrophilic coating, such as ahydrophilic catheter shaft). The injected fluid may be dispensed inimmediate proximity of the adhesion location for rehydration, or canfollow blood flow as indicated by arrows 606.

A second catheter assembly 101 in a procedure may become attached at anattachment location 702 as shown in FIG. 7. The injected fluid may helprelease the catheter assembly 101 from the adhesion location(s) 702.Also, as shown in FIG. 7, catheter assembly 100 could be used in thesame TAMBE procedure for imaging purposes. The sheath apertures 122 ofsheath 104 may be located near one side of an implant end (e.g.,endoprosthesis end 708) and catheter assembly distal end 116 may belocated near an implant opposing end (e.g., endoprosthesis end 710). Aspreviously referenced, any of a variety of fluids are contemplated fordelivery with catheter assembly 100, including contrast solution,saline, medicaments, blood, serum, or other fluids.

In various examples, the sheath 104 can be utilized to deliver a fluidbetween sheath inner surface 200 and the catheter outer surface 103. Inone example, the sheath can be infused with a contrast solution via oneof the fluid delivery ports (112,110), although any of a variety offluids including saline, medicaments, blood, serum, or other fluids arealso contemplated. The fluid is pushed through one of the ports(112,110) to generate internal fluid pressure, along hub fluid spacelength 127, and along sheath 104 creating a sheath fluid channel 400,401(e.g., a partial fluid channel or a full fluid channel) as the sheath104 enlarges (e.g., in diameter as shown in FIGS. 2C, 2D, 4C) between arelaxed or resting state (e.g., diameter) and a full or pressurizedstate (e.g., diameter). The fluid may flow along the catheter assembly100, between one of the fluid delivery ports (112,110) and sheathapertures 122, creating a sheath fluid channel 400, 401 between thecatheter outer surface 103 and the sheath inner surface 200, until thefluid can exit sheath apertures 122 near the sheath distal end 118. Thefluid may also, or alternatively, flow along the catheter assembly 100and exit catheter assembly distal end 116 via catheter lumen 119. Insome examples, the sheath transitions to the pressurized configurationupon application of an internal fluid pressure and returns towards therelaxed configuration and away from the pressurized configuration whenthe internal fluid pressure is released. When the fluid pressure hasbeen released, (e.g., when the fluid has exited sheath aperture 122) thesheath 104 can retract towards a more relaxed state. The sheathapertures 122 may be between a sheath outer surface 105 and a sheathinner surface 200 and therefore be in a sheath wall. Alternatively, thesheath 104 may have openings formed at the sheath distal end 118,similarly to a partial fluid channel 401 as shown in FIG. 2C.

A catheter assembly according to present disclosure can be manufacturedin various ways. One way is as follows. A 4.25 mm OD stainless steelmandrel was obtained and a distensible ePTFE film (e.g., an ePTFE filmwith an elastomer as taught by US Patent Application Number 2013/0184807to Kovach et. al.) was obtained. The ePTFE film should have strength ina longitudinal direction, i.e., along length of the mandrel, and bedistensible in a circumferential direction relative to the mandrel, inorder to enable a fluid space to form when pressurized by an externalsource. Approximately 4 layers of the ePTFE film were wrapped around thecircumference of the mandrel in the fashion of a cigarette wrap with anoverlapping edge of the film oriented to be parallel to the longitudinalaxis of the mandrel.

After the ePTFE film was wrapped onto the mandrel, loose edges weretacked down with a local heat source (Weller Soldering machine, ApexTool Group, Apex, N.C. 27539, USA). The ePTFE film was heat treated onthe mandrel with a heat source (e.g., a convection oven, Grieves ModelNT-1000, The Grieve Corporation, Round Lake, Ill. 60073-2898 USA) for 10minutes at 300 C. The mandrel with the ePTFE film was removed from theheat source and allowed to air cool. The ePTFE film (now an ePTFEtubular sheath) was removed from the mandrel by sliding the ePTFEtubular sheath off the mandrel. Sheath apertures were formed with asewing needle that was heated for approximately 1 minute at 250 C (othermethods or tools may be used to create apertures) by penetrating theePTFE sheath with the heated sewing needle.

A 4 mm outside diameter polymer tube with a 3.33 mm (i.e., 10 French)inner lumen, to be used as the catheter, and a dual port hub (as shownin FIG. 5A), were obtained. The hub was adhered to the polymer tube withan UV cure adhesive (other known methods of adhering a hub to a cathetermay be used). The polymer tube had an effective length of 318 mm afterthe hub was overmolded onto the polymer tube. The ePTFE sheath (sheath)was pulled along the catheter (i.e., polymer tube) and attached to thehub with an adhesive (e.g., cyanoacrylate). The sheath was trimmedapproximately 5 mm distal of the apertures in the sheath so the ePTFEsheath had a desired length (293 mm) as measured from end of the sheathto distal end of the hub. The sheath was attached to the catheter withan adhesive (e.g., cyanoacrylate) at the trimmed location. In this way,a catheter assembly having a low profile fixed length sheath capable ofbeing enlarged (e.g., diametrically) to create a fluid space along thesheath; and a catheter with infusion ports where at least one of theinfusion ports cooperates with the sheath was made.

In addition to the teachings described above and claimed below, devicesand/or methods having different combinations of the features describedabove and claimed below are contemplated. As such, the description isalso directed to other devices and/or methods having any other possiblecombination of the dependent features claimed below.

Numerous characteristics and advantages have been set forth in thepreceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications may be made, especially in matters of structure,materials, elements, components, shape, size and arrangement of partsincluding combinations within the principles of the invention, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

1. A catheter assembly having a length comprising: an elongate memberhaving a first fluid channel; a sheath along the elongate member andselectively attached to the elongate member, the sheath having a firstrelaxed configuration and a second pressurized configuration andcooperating with the elongate member to form a second fluid channel; afirst delivery port in communication with the first fluid channeladapted to deliver a fluid through the first fluid channel to a firstlocation along the length of the elongate member; and a second deliveryport in communication with the second fluid channel adapted to deliver afluid through the second fluid channel to a second location along thelength of the elongate member.
 2. The catheter assembly of claim 1,wherein the sheath is attached to a hub including the first deliveryport and the second delivery port.
 3. The catheter assembly of claim 1,wherein the elongate member is attached to a hub.
 4. The catheterassembly of claim 1, wherein the sheath further comprises a distal endand the sheath is attached to the elongate member near the distal end ofthe sheath.
 5. The catheter assembly of claim 1, wherein the sheath isattached entirely around a portion along the length of the elongatemember.
 6. The catheter assembly of claim 1, wherein the first relaxedconfiguration has a circumference around the sheath and the secondpressurized configuration has a circumference around the sheath, and thesecond pressurized configuration circumference around the sheath isgreater than the first relaxed configuration circumference around thesheath.
 7. The catheter assembly of claim 1, wherein the sheathtransitions to the pressurized configuration upon application of aninternal fluid pressure and returns towards the relaxed configurationand away from the pressurized configuration when the internal fluidpressure is released.
 8. The catheter assembly of claim 1, furthercomprising an endoprosthesis.
 9. The catheter assembly of claim 1,wherein the elongate member is a shaft of a catheter.
 10. The catheterassembly of claim 1, wherein the catheter assembly is configured forhydrating biological tissue of a body conduit.
 11. A catheter assemblycomprising: an elongated element with an outer surface, a first end anda second end, a length extending between the first end and the secondend, and a lumen extending along the elongated element; a sheathsurrounding at least a portion of the length of the elongated element;wherein the sheath comprises a wall thickness, an outer surface area,and a first relaxed configuration and a second pressurized configurationupon application of an internal fluid pressure within the sheath;wherein the sheath is attached circumferentially to the elongatedelement at a location distal to at least one macroscopic sheathaperture, and the sheath is attached circumferentially to anotherportion of the catheter assembly at an opposing end of the sheath, andwherein the sheath cooperates with the elongated element to form achannel when the sheath is in the second pressurized configuration; andwherein said at least one macroscopic aperture has a macroscopicaperture area that occupies 20% or less of surface area of the sheath.12. The catheter assembly of claim 11, wherein the sheath returnstowards the relaxed configuration and away from the pressurizedconfiguration when the internal fluid pressure is released.
 13. Thecatheter assembly of claim 11, wherein there are multiple macroscopicapertures clustered along a location near a distal end of the sheath.14. A medical procedure comprising: delivering an elongated element of acatheter assembly into a vasculature of a body, the elongated elementhaving an outer surface, a first end and a second end, a lengthextending between the first end and the second end, and a lumenextending along the elongated element, the catheter assembly including asheath surrounding at least a portion of the length of the elongatedelement, the sheath comprising a wall thickness, an outer surface area,and a first relaxed configuration and a second pressurized configurationupon application of an internal fluid pressure within the sheath, thesheath being attached circumferentially to the elongated element at alocation distal to at least one macroscopic sheath aperture, and beingattached circumferentially to another portion of the catheter assemblyat an opposing end of the sheath, wherein the sheath cooperates with theelongated element to form a channel when the sheath is in the secondpressurized configuration; and pressurizing the channel to transitionthe sheath from the first relaxed configuration to the secondpressurized configuration with a fluid such that the fluid is deliveredfrom the at least one sheath aperture into the vasculature.
 15. Themedical procedure of claim 14, wherein the fluid is contrast.
 16. Themedical procedure of claim 14, wherein the fluid comprises one or moreof saline, blood, serum, and medicaments.
 17. The medical procedure ofclaim 14, wherein the fluid delivered from the at least one sheathaperture into the vasculature is used to hydrate the vasculature or thecatheter assembly to facilitate removal of catheter assembly from thevasculature.